Dialectical Behavioral Therapy Skills for Impulsive Aggression

NCT ID: NCT05351944

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-07
• Study Completion Date: 2024-05-18

Brief Summary

This trial aims to Study the efficacy of DBT skills for impulsive aggression and executive dysfunctions in drug naïve children who are presented with impulsive aggression and ADHD and attending Child and adolescent clinic at Alexandria university hospitals using weekly group therapy for 8 month and testing pre and posttreatment biomarkers of aggression.

Conditions

Impulsive Aggression; ADHD; Executive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The intervention group (group A) DBT skills

Will attend Dialectical Behavioral Therapy skills group for both the children and their parents, DBT is an evidence based comprehensive cognitive behavioral treatment for complex mental disorders and have been adapted for intractable behavioral disorders involving emotion dysregulation, skills will be provided in group therapy as fixed weekly sessions over 9-month duration for all the children and the parents in group A including:

1. Emotion regulation skills module over 8 weeks.

2. Mindfulness skills module over 3 weeks

3. Interpersonal effectiveness skills module over 7 weeks.

4. Distress tolerance skills module over 8 weeks.

5. Walking the middle path skills module over 3 weeks.

Group Type: EXPERIMENTAL

Dialectical behavioral therapy skills for the intervention experimental group A

Intervention Type: BEHAVIORAL

Our hypothesis is that impulsive aggression as evidenced by inflammatory biomarkers might improve by targeting executive dysfunctions with Dialectical Behavioural Therapy skills modules directed to the children and their parents in the form of response inhibition dysfunctions with Dialectical Behavioural Therapy mindfulness and distress tolerance skills modules, emotion regulation executive dysfunctions with Dialectical Behavioural Therapy emotion regulation skills module and socioenvironmental factors with interpersonal effectiveness and walking the middle path Dialectical behavioural therapy skills modules.

the control group (group B)

Will receive psychoeducation and medications targeting ADHD symptoms (stimulants or atomoxetine according to FDA approved dose per age and weight) according to the international guidelines for management of ADHD according to symptom severity, given that assessment before and after intervention will be done by different medical personnel than those providing the intervention for the two groups.

Group Type: ACTIVE_COMPARATOR

psychoeducation or Atomoxetine or stimulants according to ADHD severity

Intervention Type: DRUG

the control group (group B) will receive psychoeducation and medications targeting ADHD symptoms (Atomoxetine or stimulants according to FDA approved dose according to age and weight ) according to the international guidelines for management of ADHD according to symptom severity

Interventions

Dialectical behavioral therapy skills for the intervention experimental group A

Our hypothesis is that impulsive aggression as evidenced by inflammatory biomarkers might improve by targeting executive dysfunctions with Dialectical Behavioural Therapy skills modules directed to the children and their parents in the form of response inhibition dysfunctions with Dialectical Behavioural Therapy mindfulness and distress tolerance skills modules, emotion regulation executive dysfunctions with Dialectical Behavioural Therapy emotion regulation skills module and socioenvironmental factors with interpersonal effectiveness and walking the middle path Dialectical behavioural therapy skills modules.

Intervention Type: BEHAVIORAL

psychoeducation or Atomoxetine or stimulants according to ADHD severity

the control group (group B) will receive psychoeducation and medications targeting ADHD symptoms (Atomoxetine or stimulants according to FDA approved dose according to age and weight ) according to the international guidelines for management of ADHD according to symptom severity

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients from 6 to 13-year-old.
• Patients diagnosed with ADHD and presented with impulsive aggression.
• Commitment to therapy from the child and the parent.
• Written consent of all the children parents.
• Male gender.
• Drug naïve or stopped medications for at least one month.

Exclusion Criteria

• Patients younger than 6 years of age as it's the starting age for DBT-C.
• Patients who dropped from DBT skills group (missing more than 3 consecutive sessions) whether the child or his parent.
• Patients diagnosed with drug abuse.
• Patients with severe sensory impairment or intellectual disability.
• Drug induced aggression as levetiracetam, topiramate and benzodiazepines.
• Patients diagnosed with Autism spectrum disorder or psychotic disorders.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Aya Maged

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

aya maged, master

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Alexandria university

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

850486055

Identifier Type: -

Identifier Source: org_study_id